| Objective: Adverse drug reaction(ADR) means a reaction which is noxious andunintended，and which occurs at doses normally used in man for the prophylaxis,diagnosis, or therapy of disease, or for the modification of physiological function，definition excludes accidental or deliberate excessive dosage or maladministration. It isa risk which usually accompany with the normal drug therapy.Adverse drug reactionmonitoring is not only a very important content of drug post-marketing studies but alsoa kind of effective method to strengthen the post-marketing drug safety regulation andto ensure a safe and effective human medication. In our country, spontaneous reportingsystem（SRS) is used for monitoring adverse drug reactions,which is the mostimportant measure for adverse drug reaction monitoring all over the world. In theimplementation of spontaneous reporting system, those self-reported ADR reports arethe main sources for discovering the new adverse drug reactions signals ofpost-marketing drugs. This study is going to develop a practical software packageincluding data collecting function, data processing function and monitoring&warningfunction, in order to achieve the automation of the ADR data extraction and adversedrug reaction signal detection and make data pre-processing faster and moreconvenient. Methods: This software package was developed under Microsoft Visual Studio2005development environment using Microsoft Office Access and Excel as supports withMicrosoft Visual Basic6.0and C++programming languages.It made references to thedomestic and international major ADR signal quantitative detection methods such asPRR,ROR and MHRA in detecting suspicious adverse drug reaction signals from thespontaneous reporting system. This study established the database according to thefields of ADR reports and used adverse drug reaction reports reported by hospital asanalysis data to do the analysis.Results: According to the latest Adverse Drug Reaction Reporting and MonitoringManagement Approach (Ministry of Health Order No.81) that was promulgated onMay4,2011, we can only analyze the records of ADR reports which were reported inthe whole year of2012. This study obtained3466ADR reports which were providedrespectively by Anhui Provincial Hospital and Yijishan Hospital of Wannan MedicalCollege. Each ADR signal quantitative detection method was able to show the top20drug-ADR combinations of highest frequency of occurrence in the records.Conclusion: After comparison, the results show that the adverse drug reactionmonitoring software is quite practical. And to a certain extent it can make adverse drugreaction monitoring more systematic, make the methods more standard, make theindicators more quantitative and make the results more scientific. At the same time, thesoftware application not only can be used as a scientific basis for Drug Administrationto strengthen the management of drug but also can provide the basis for guiding theclinical rational drug use. |
